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USE: AndroGel® (testosterone gel) 1% and 1.62%

AndroGel® (testosterone gel) 1% and 1.62% are controlled substances, available by prescription, used to treat adult males who have low or no testosterone.It is not known if AndroGel is safe or effective in children younger than 18 years old.Testosterone products that are applied to the skin may have different doses, strengths, or application instructions that may lead to different levels of testosterone in your body.

Important Safety Information

AndroGel can transfer from your body to others. This can happen if other people come into contact with the area where AndroGel was applied.

Signs of puberty that are not expected have happened in young children who were accidentally exposed to testosterone through skin-to-skin contact with men using topical testosterone products like AndroGel.

Women and children should avoid contact with the unwashed or unclothed area where AndroGel has been applied. If a woman or child makes contact with the AndroGel application area, the contact area on the woman or child should be washed well with soap and water right away.

To lower the risk of transfer of AndroGel 1.62%, you should apply it only to your shoulders and upper arms, areas that will be covered by a short-sleeve T-shirt. Do not apply AndroGel 1.62% to any other parts of your body, such as your stomach area (abdomen), penis, scrotum, chest, armpits (axillae), or knees. Wash your hands right away with soap and water after applying. After the gel has dried, cover the application area with clothing until you have washed the application area well or have showered. If you expect another person to have skin-to-skin contact with your shoulders or upper arms, first wash the application area well with soap and water.

To lower the risk of transfer of AndroGel 1%, you should apply it only to areas that will be covered by a short-sleeve T-shirt. These areas include shoulders, upper arms, and stomach area. Do not apply AndroGel 1% to any other parts of your body such as your penis, scrotum, chest, armpits (axillae), knees, or back. Wash your hands right away with soap and water after applying AndroGel. After the gel has dried, cover the application area with clothing. If you expect to have skin-to-skin contact with another person, first wash the application area well with soap and water.

Stop using AndroGel and call your healthcare provider right away if you see any signs and symptoms of puberty in a child, or changes in body hair or increased acne in a woman, that may have occurred through accidental exposure to AndroGel.

Do not use AndroGel if you have breast cancer or have or might have prostate cancer.

AndroGel is not meant for use in women and must not be used in women who are or may become pregnant or are breastfeeding. AndroGel may harm the unborn or breastfeeding baby. Women who are pregnant or who may become pregnant should avoid contact with the area of skin where AndroGel has been applied.

Before you use AndroGel, tell your healthcare provider if you have breast cancer; prostate cancer; urinary problems due to enlarged prostate; heart, kidney, or liver problems; problems breathing while you sleep (sleep apnea); or have any other medical conditions.

AndroGel can cause serious side effects, including:

If you already have enlargement of your prostate gland, your signs and symptoms can get worse while using AndroGel (including changes in urination)

Possible increased risk of prostate cancer

In large doses, AndroGel may lower your sperm count

Swelling of your ankles, feet, or body, with or without heart failure. This may cause serious problems for people who have heart, kidney, or liver disease

Enlarged or painful breasts

Having problems breathing while you sleep (sleep apnea)

Blood clots in your legs or lungs. Signs and symptoms of a blood clot in your leg can include leg pain, swelling, or redness. Signs and symptoms of a blood clot in your lungs can include difficulty breathing or chest pain.

Tell your healthcare provider about all the medicines you take, especially if you take insulin, medicines that decrease blood clotting, or corticosteroids.

AndroGel is flammable until dry. Let AndroGel dry before smoking or going near an open flame.

The most common side effects of AndroGel 1.62% are increased prostate specific antigen (a test used to screen for prostate cancer), mood swings, high blood pressure, increased red blood cell count, and skin irritation where the gel is applied. The most common side effects of AndroGel 1% are acne, skin irritation where the gel is applied, increased cholesterol levels, increased prostate specific antigen, increased red blood cell count, and increased liver function tests.

AndroGel 1% and 1.62% application sites and dosages are not interchangeable with each other or with other topical testosterone products.

This is the most important information to know about AndroGel. For further information, talk with your healthcare provider.